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Neuroimaging the Expectancy Versus Pharmacotherapy Effect of Adderall on Cognitive Performance

NCT ID: NCT03530631

Last Updated: 2019-12-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-10

Study Completion Date

2018-12-18

Brief Summary

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The purpose of this balanced-placebo design study is to pilot a larger study to further explore the current evidence that stimulant medications are not cognitive enhancers, despite this rampant belief in young adults. While the lack of cognitive enhancement from stimulant medication has been documented in prior research, this study is the first to utilize neuroimaging technology to examine brain regions activated during neurocognitive tasks when participants believe they have been administered stimulant medication or placebo.

Detailed Description

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This is a 2 X 2 within subjects, balanced placebo design and all participants will experience each of the four conditions during four sequential weeks. Medication administered (Adderall vs. placebo) is crossed with instructional set (truth vs. deception) and participants' performance on neurocognitive tasks is compared across these groups. For example, participants are either given stimulant medication or placebo, and are either accurately told or inaccurately told that they received stimulant medication or placebo. Neuroimaging is being utilized to investigate whether participants' expectations regarding the benefits of stimulant medication affects their performance on neurocognitive tasks. The hypothesis of the study is that participants' expectations regarding stimulant medication will affect their performance on neurocognitive tasks, rather than the actual effect of the medication.

Conditions

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Expectancy Versus Pharmacotherapy Effect of Adderall

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

2 X 2, within-subjects, balanced placebo design
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators
This will be a double-blind study. Research assistants will administer capsules, and based on package labeling, tell the participant if they are being administered Adderall or placebo. However, researchers and participants will be blind to which medication is actually being administered.

Study Groups

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Adderall/Truth

Participants will be told they are receiving Adderall and will actually be administered Adderall.

Group Type EXPERIMENTAL

Adderall

Intervention Type DRUG

Participants will be administered Adderall

Placebo/Truth

Participants will be told they are receiving placebo and will actually be administered placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants will be administered placebo

Adderall/Deception

Participants will be told they are receiving Adderall and will actually be administered placebo.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Participants will be administered placebo

Placebo/Deception

Participants will be told they are receiving placebo and will actually be administered Adderall.

Group Type EXPERIMENTAL

Adderall

Intervention Type DRUG

Participants will be administered Adderall

Interventions

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Adderall

Participants will be administered Adderall

Intervention Type DRUG

Placebo

Participants will be administered placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age (18-24)
* College student with at least average IQ
* Willingness to standardize caffeine intake to 100 mg on day of study

Exclusion Criteria

* Attention Deficit/Hyperactivity Disorder (ADHD)
* First degree relative with ADHD
* Unwillingness to comply with caffeine specifications
* Regular use of Adderall
* Pregnant/breastfeeding
* History of substance use disorders
* Illicit stimulant use within the last year
* Contraindications to stimulants (i.e., tics, Tourette's, cardiac disease, hypertension)
* Uncontrolled medical illness
* Active contagious infection
Minimum Eligible Age

18 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Karen Cropsey

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen Cropsey, Psy.D.

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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IRB-300000343

Identifier Type: -

Identifier Source: org_study_id